METHOD FOR STERILIZATION OF HUMAN PLASMA AND PLATELETS

人血浆和血小板的灭菌方法

• 批准号: 2864911
• 负责人: Robert Raulli
• 金额: $ 9.97万
• 依托单位: DORLIN PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-15 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2864911
• 关键词: antibiotics; antiseptic sterilization; blood banks; human tissue; method development; morphology; plasma; platelets; tissue /cell preparation

This proposal is to develop a method to prolong the self-life and increase the safety of human platelets with a unique method of sterilization. The method delivers an agent known to kill a broad range of microbial pathogens in vitro including bacterial species known to contaminate platelet concentrates, as well as fungi, parasites, and viruses. The lethal agent can be released from an insoluble polymer that can be incorporated into the plastic that comprises the collection bag. The agent breaks down rapidly to normal physiological by-products, and thus presents little danger to the patient. Successful development of this method will increase the safety of the platelet and plasma supply, and by inhibiting microbial growth, increase shelf-life of platelets. Human plasma will be inoculated with common microbial contaminants of human platelet concentrates, and experiments performed to determine agents with optimal half-lives for antimicrobial efficacy. Efficacious compounds will then be tested in human platelet concentrates under blood bank conditions of handling and storage. Assessment of the effects of the compounds on the physiology of platelets will also be determined. PROPOSED COMMERCIAL APPLICATIONS: Successful development of a simple, inexpensive and effective process to sterilize plasma and platelet concentrates has the potential to become incorporated into every plasma and platelet collection container produced, roughly 20 million each year in the US. The economic incentive for this project is to develop agents to sterilize, and thus, prolong platelet shelf- life. The ability to significantly increase shelf-life of platelet concentrates could save blood banks millions of dollars each year.

该建议是开发一种通过独特的灭菌方法来延长自我生命并提高人类血小板安全性的方法。该方法提供了一种已知杀死广泛的体外微生物病原体的药物，包括已知可污染血小板浓缩物的细菌，以及真菌，寄生虫和病毒。可以从不溶性聚合物中释放致命剂，该聚合物可以掺入包含收集袋的塑料中。该药物迅速分解为正常的生理副产品，因此对患者的危险很小。这种方法的成功开发将提高血小板和血浆供应的安全性，并通过抑制微生物的生长，增加血小板的保质期。 人血浆将与人血小板浓缩物的常见微生物污染物接种，并进行实验，以确定具有最佳半衰期抗菌功效的最佳半衰期的药物。然后，在血液库处理和储存条件下，将在人血小板浓缩物中测试有效的化合物。还将确定化合物对血小板生理的影响的评估。拟议的商业应用：成功开发一个简单，廉价且有效的过程，以消毒血浆和血小板浓缩物，有可能将其纳入每个产生的等离子体和血小板收集容器中，每年约2000万。该项目的经济动力是开发代理商进行消毒，从而延长血小板架子。显着增加血小板浓缩物的保质期的能力每年可以为血库节省数百万美元。